Labor Scale Versus WHO Partograph for Management of Labor (ScaLP)
Study Details
Study Description
Brief Summary
The current study aims at evaluating the impact of the implementation of the labor scale, in comparison to the standard WHO partograph, in the management of primiparous women, including CD rate, maternal and neonatal outcomes of labor.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Since the procedure was first introduced to clinical practice, Cesarean delivery (CD) has significantly contributed to peripartum maternal and fetal safety when appropriately indicated. Nevertheless, CD rate has significantly increased over the last two decades without parallel improvement in maternal or neonatal outcomes. Globally, one out of three pregnancies would be delivered by CD, resulting in growing surgical, obstetric and financial burden. Over years, long-term sequelae of current CD rate have become evident such as increased incidence of placenta accreta spectrum and exponential rise in CD trend, since 90% of women who had CD are susceptible to CD in future pregnancies. These concerns have triggered a global act to control CD rates within the margins of safe obstetric practice.
The most common indication of CD is labor dystocia. However, the definition of labor dystocia is inconsistent, and standardization of diagnosis has been heavily investigated. The WHO partograph was established at the end of the last century to serve as a tool to recognize labor dystocia and has been universally accepted to verify CD decision However, a cochrane review by Lavender et al. revealed that role of WHO partograph, in improving clinical outcomes, is lacking. In addition, there is no evidence that any published modification of the current partograph is superior to another. The "labor scale," a novel alternative to the classic partograph, was first introduced to literature in 2014. The tool was designed based on evidence-based guidelines and integrates both diagnosis and interventions to manage labor dystocia. Initial data showed that labor scale contributed to decreased incidence of CD and oxytocin administration. However, further studies are required to verify these results.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Labor scale Observation Amniotomy Oxytocin Cesarean Section (CS) |
Procedure: Amniotomy
Amniotomy, artificial rupture of membranes, is done with an initial delay of labor (in partograph: extension beyond the alert line, in labor scale: when progress reaches the membrane line)
Other Names:
Drug: Oxytocin
oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
Other Names:
Procedure: Cesarean Section
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Other Names:
|
| Active Comparator: WHO partograph Observation Amniotomy Oxytocin Cesarean Section (CS) |
Procedure: Amniotomy
Amniotomy, artificial rupture of membranes, is done with an initial delay of labor (in partograph: extension beyond the alert line, in labor scale: when progress reaches the membrane line)
Other Names:
Drug: Oxytocin
oxytocin augmentation: given with further delay of labor (according to the point of intervention of the partograph or the scale)
Other Names:
Procedure: Cesarean Section
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported) [Duration of labor (maximum 24 hours from onset of labor)]
The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia
Secondary Outcome Measures
- Intrapartum maternal birth injuries [Duration of labour and hospital stay (anticipated duration: 72 hours)]
This is assessed clinically at the time of labor, and includes the extent of vaginal and perineal traumas and type of repair
- Primary postpartum hemorrhage [Within 24 hours of delivery]
Primary postpartum hemorrhage is defined as estimated blood loss > 500 ml following delivery and within 24 hours postpartum
- Maternal fever/postpartum infections [Within 24 hours of delivery]
This is indicated by a single temperature at or above 38.0 c or 2 measurements at or above 37.5 c.
- Intrapartum fetal distress [Duration of labor (maximum 24 hours)]
This criterion is met if cardiotocography shows signs consistent with pathological tracing as defined by NICE guidelines (persistent late or variable decelerations, prolonged bradaycardia or sinusoidal rhythm)
- Birth injuries of the newborn [The length of neonatal hospital stay (anticipated duration: 72 hours)]
Presence of bony fractures, cephalhematoma, or intracranial hemorrhage as evident by physical examination of the newborn
- Neonatal distress "asphyxia" [The length of stay in hospital/neonatal intensive care unit (anticipated duration: 72 hours)]
This is indicated by 1 and 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to neonatal intensive care unit, length of stay and any further medical complications
- Duration of labor in hours [Duration of labor (maximum 24 hours)]
This starts from the onset of active labor (3 cm or more of cervical dilation) till actual delivery
- Incidence of oxytocin use [Duration of labor (maximum duration: 24 hours)]
Incidence of administration of intravenous oxytocin during labor for labor augmentation
- Incidence of instrumental delivery [Duration of labor (maximum duration: 24 hours)]
Instrumental delivery includes forceps and ventouse deliveries
Eligibility Criteria
Criteria
Inclusion Criteria Pregnant women aged 18 to 45 years old with the following criteria:
nulliparous, had been pregnant for 37 to 41 weeks with a singleton viable fetus, and vertex presented, and with estimated fetal weights between 2,500 and 4,500 g.
Exclusion Criteria Women with following criteria will be excluded: significant maternal medical or surgical comorbidity, previous uterine scar
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aswan Faculty of Medicine | Aswan | Egypt | 81528 |
Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine, Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026.
- Gregory KD, Jackson S, Korst L, Fridman M. Cesarean versus vaginal delivery: whose risks? Whose benefits? Am J Perinatol. 2012 Jan;29(1):7-18. doi: 10.1055/s-0031-1285829. Epub 2011 Aug 10. Review.
- Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics. 2013 Mar;131(3):548-58. doi: 10.1542/peds.2012-3769. Epub 2013 Feb 11.
- HealthyPeople.gov. Search the Data | Healthy People 2020 [Internet]. 2017 [cited 2022 Mar 28]. p. 1-6. Available from: https://www.healthypeople.gov/2020/data-search/Search-the-Data#objid=4660;
- Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8:CD005461. doi: 10.1002/14651858.CD005461.pub5.
- Neal JL, Ryan SL, Lowe NK, Schorn MN, Buxton M, Holley SL, Wilson-Liverman AM. Labor Dystocia: Uses of Related Nomenclature. J Midwifery Womens Health. 2015 Sep-Oct;60(5):485-98. doi: 10.1111/jmwh.12355. Review.
- Shazly SA, Embaby LH, Ali SS. The labour scale--assessment of the validity of a novel labour chart: a pilot study. Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):322-6. doi: 10.1111/ajo.12209. Epub 2014 May 17.
- Tolba SM, Ali SS, Mohammed AM, Michael AK, Abbas AM, Nassr AA, Shazly SA. Management of Spontaneous Labor in Primigravidae: Labor Scale versus WHO Partograph (SLiP Trial) Randomized Controlled Trial. Am J Perinatol. 2018 Jan;35(1):48-54. doi: 10.1055/s-0037-1605575. Epub 2017 Aug 8.
- MCOG1-22